regulatory information management systems (RIMS)

RIMS offers life sciences organizations a streamlined, collaborative approach to regulatory data management, ensuring consistent compliance and enabling data-driven decisions. With tools like workflow automation and data visualization, companies can expedite product registration, enhance cross-team collaboration, gain insights from KPIs, and ensure adherence to evolving global regulations.

RIMS Industry Perspective

An important industry trend is health authorities' changing regulations for data-oriented information exchange. Although paper-based processes have been largely phased out, data requirements have only become more sophisticated.

One example is the European Medicine Agency's Identification of Medicinal Products (IDMP) mandate, which introduces new stipulations on data elements and structures to uniquely identify medicinal products and substances. Organizations seeking to comply with IDMP must have established processes for data collection and evaluation. They may also need to perform remediation.

People working at a table with medical and computer devices
Business professionals working with charts and graphs at a table

What is Regulatory Information Management (RIM)?

Regulatory Information Management is a set of processes used to collect, manage, and archive information in accordance with regulatory requirements. For life science companies, RIM can be a complex, time-intensive effort, but it is essential to ensure compliance and protect patients.

RIM comprises all information that is required by regulators to ensure safety, efficacy, and product quality. Examples include clinical trial information, safety data, manufacturing specifications, labeling information, marketing materials, regulatory submissions, and health authority correspondence.

What is a Regulatory Information Management System (RIMS)?

Regulatory Information Management Systems (RIMS) is any software solution that enables life sciences organizations to utilize regulatory information to bring products to market. There are four key benefits of RIMS.

functional-service-provider

Streamline Regulatory Data Management

Streamline Regulatory Data Management

RDTechnology

Enhance Collaboration

Enhance Collaboration

ResearchPlatforms

Contextualize Data

Contextualize Data

quality-compliance

Ensure Regulatory Compliance

Ensure Regulatory Compliance

Streamline Regulatory Data Management

Expedite the creation of new product registration applications and documents through a cloud-based repository that is available 24/7. Software can save critical time compared to paper-based methods or use of disparate systems. One centralized repository breaks down data siloes and permits strategy of re-using data across the company.

Business Professionals pointing at papers with their fingers

Enhance Collaboration

Teams based in different regions can leverage built-in tools such as workflows and document editors to collaborate both asynchronously and simultaneously. RIMS reduces reliance on multiple communication methods out of the system; instead, instructions and comments provided within RIMS are considered most up-to-date. These capabilities cut down on miscommunications and rework.

Hands gesturing over data and charts on papers

Contextualize Data

Many RIMS provide data visualization tools or reports. For example, a system-generated report on submissions past their initial submission due date can help teams identify patterns and areas of improvement. These features provide insight into key performance indicators (KPIs) and empower regulatory stakeholders to make data-driven decisions.

Group of professional women talking in a lobby

Ensure Regulatory Compliance

RIMS commonly feature workflow automation, which accelerates the regulatory approval process and reduces human error. By standardizing processes within the system, organizations can ensure that users consistently follow company policies and the latest regulations. By implementing a RIM solution, organizations minimize legal risks of non-compliance by ensuring consistent treatment of the relevant regulations in each market.

Business and healthcare professionals smiling around charts

The Impact of Effective RIMS Software. Consider the following scenarios:

qppv-office

Leadership hopes to accelerate the product-to-market process.

RIMS enables regulatory process improvements that significantly sharpen your organization’s innovative edge and differentiation from...

Read More

Leadership hopes to accelerate the product-to-market process.

RIMS enables regulatory process improvements that significantly sharpen your organization’s innovative edge and differentiation from competitors.

Read Less
safety-systems

Legal needs to reference a product specification that may be involved in litigation.

RIMS allows the system administrator to preserve the document as-is, ensuring no users are editing or deleting it.

Legal needs to reference a product specification that may be involved in litigation.

RIMS allows the system administrator to preserve the document as-is, ensuring no users are editing or deleting it.

Read Less
regulatory-operations

Regulators mandate that new information is required to uniquely identify products.

A new metadata field is created in RIMS and made required for users. By the time that submissions are completed, you...

Read More

Regulators mandate that new information is required to uniquely identify products.

A new metadata field is created in RIMS and made required for users. By the time that submissions are completed, you are confident that the information has been added to all relevant documents and have system capabilities to track it.

Read Less

RIMS Software Vendors

There are numerous RIMS vendors in the life sciences space, all of which generally provide submission tracking, workflow automation, and document version control capabilities. We've listed three well-known solutions below:

  • Documentum for Life Sciences (OpenText): Cloud-native platform that includes module specific to submission/correspondence storage and viewing. Accessible via web or mobile. Unique features include flexible upgrade timing and the ability to choose your preferred cloud infrastructure. 
  • EXTEDOpulse (EXTEDO): Comprehensive RIMS solution with five modules: Planning and Tracking, Document Management, Registration Management, Safety Management, and Submission Management.  
  • Veeva Vault RIM Suite (Veeva Systems): Cloud-based platform comprising four distinct applications: Submissions, Submissions Archive, Registrations, and Publishing. Vault Submissions has been adopted by 100+ organizations and is popular among enterprise companies. 
professionals-discussing-around-a-conference-table

ProPharma's RIM Services & Approach

ProPharma’s R&D Technology team excels in aligning your companies' needs with regulations and GxP system best practices. Our comprehensive approach and expert knowledge ensure that your organization maintains the highest standards of quality and regulatory compliance across the GxP landscape. Our team has decades of combined experience in the following areas:

Service Category

How We Can Help

Strategy & Business Process Optimization

  • System Selection
  • Roadmap Development

Regulatory Operations

  • Staff Augmentation

Implementation Support

  • Project Management
  • Configuration
  • Data Governance and Migration
  • Controlled Document Creation (SOPs and Job Aids)
  • Training

Validation

  • Validation Coordination
  • User Acceptance Test Scripts

Managed Services

  • Release Management

RIMS Consulting Expertise

If you are interested in implementing or optimizing RIMS, ProPharma's R&D Technology team comprises experienced consultants who can advise your digital transformation. If you are interested in partnering with ProPharma on any of the services above, contact us via the form below. We look forward to working with you!

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